China deliberates stricter regulations on human gene studies

In November 2018, Chinese researcher Jiankui He’s announced the birth of the world’s first genetically edited babies using the CRISPR-Cas9 genome editing tool. This announcement was followed by an outcry from Chinese as well as international researchers. Now Chinese legislators are planning to implement a new set of regulations on gene editing in humans.

In China, the civil code is the overarching law governing non-criminal disputes concerning personal rights of citizens. In order to tighten the rules around human genome editing, the legislators in China are set to include a new clause in the “personality rights” section of the civil code. As per the new clause, researchers conducting studies related to human genes or embryos will have to “abide by laws, administrative rules and relevant regulations.” It should be ensured that the participants’ health remains unaffected and their moral rights are protected.

Earlier this month, four prominent bioethicists from China wrote an article in Nature where they emphasized the need for the Chinese government to “make substantial changes to protect others from the potential effects of reckless human experimentation.”  

This is the first time definitive steps have been taken to regulate genome studies in China. "It is necessary to emphasize regulation of medical or scientific studies related to human genetic information in the civil code, which is considered the most fundamental privacy for all citizens," said Liu Changqiu, a health law expert and research fellow at the Shanghai Academy of Social Sciences.

The Standing Committee of the National People’s Congress – the chief legislative body in the country – received the latest civil code draft with the regulations around human gene studies last month. It is likely that the draft will be passed and adopted in the next year.

Related reading:

• Chinese researcher claims world's first gene-edited babies' birth, sparking global uproar
• China cracks down on academic misconduct, issues tough guidelines for authors and institutions

References:

• China’s Civil Code Could Include Tightened Provisions on Gene Editing
• China mulls regulating human gene, embryo-related studies in personality legislation
• China set to introduce gene-editing regulation following CRISPR-baby furore
• China mulls tougher law on gene studies